Automatic identification of instruments

ABSTRACT

A system and apparatus is disclosed to automatically determine the identification and selected information relating to instruments. The identification information may be read or determined by various reader systems and then transferred for various purposes. The identification information may be stored on the instrument with a storage system or printing and/or recalled from a memory once the identification is made.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/491,599, filed on Apr. 28, 2017. This application includes subjectmatter related to U.S. patent application Ser. No. 15/963,407, filed onApr. 26, 2018. The entire discloser of the above application isincorporated herein by reference.

FIELD

A system for identification of an instrument, and particularly to asystem and method for providing and/or transferring specific informationregarding a particular instrument.

BACKGROUND

The statements in this section merely provide background informationrelated to the present disclosure and may not constitute prior art.

Surgical procedures are often performed on various patients in variousoperating theaters at different times. Many instruments are used duringa single procedure. The instruments used during a specific procedure,however, are generally specific to that procedure. Further, manyinstruments are reused for similar or identical procedures (e.g. spinalimplant placement) on different patients at different times. It may bedesirable to provide information relating to a specific instrument orattachment (e.g. tip) to an instrument among the multiple instrumentsbrought into or provided in a single operating theater, or a singleprocedure, or among multiple procedures with a single instrument.

A manual system may require a user or an assistant to enter or recordinformation about an instrument, such as a surgical instrument. Theentered information relates general use and inventory tracking about aparticular instrument. The information can be transferred to a computerto determine the location of a selected instrument in an inventory, amanufacturer of an instrument, or the like. The information relating tothe instrument, however, is generally limited to information relatingonly to inventory tracking information or limited identity information.

SUMMARY

A system, including an automatic identification system, can provideinformation about an instrument including its specific type, size,number of uses, use during a procedure, preparation for a procedure,etc. The information may be automatically entered or sent to a surgicalnavigation system. The surgical navigation system may include a trackingsystem that tracks a location (e.g. position and orientation) in asurgical space during a specific or current procedure. The trackinginformation may be used in combination with the automatically providedidentification information for use by the navigation system to properlyand accurately track a specific location of at least a portion of theinstrument.

Identification information may include calibration information, sizeinformation, configuration information, and the like that can betransferred to the navigation system from a specific instrumentdirectly. The identification information can include informationspecific to a particular procedure about a particular instrument toallow for precise tracking of the instrument during the procedure. Theidentification system can also allow for writing, rewriting,overwriting, or deleting identification information to insure up-to-dateand accurate information, particular procedure information, and the likeare always provided and correct.

Further areas of applicability will become apparent from the descriptionprovided herein. It should be understood that the description andspecific examples are intended for purposes of illustration only and arenot intended to limit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.

FIG. 1 is an environmental view of an operating room theater including asurgical navigation system, according to various embodiments;

FIG. 2 is a plan view of a plurality of instruments in a it, accordingto various embodiments;

FIG. 3A is an environmental view of an instrument and a reader systemfor automatic identification of the instrument, according to variousembodiments;

FIG. 3B is an environmental view of an instrument and a reader systemfor automatic identification of the instrument, according to variousembodiments; and

FIG. 4 is a flow/use chart of an automatic identification system.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is notintended to limit the present disclosure, application, or uses.

With initial reference to FIG. 1 a procedure room or theater 20 asillustrated. The procedure room 20 may include a surgical operatingtheater as is generally understood by one skilled in the art. It isunderstood, however, that the area or room 20 may be any appropriateroom and include any appropriate area, including those discussed herein.The surgical operating theater may include various areas or stagingtables including a first table or non-sterile table or area 22. A secondstaging area 24 that may include a first sterile table or staging area24 and a third table staging or area 26, which may also be a sterilearea. Each of the tables or staging areas may be used for variousportions or preparations for a procedure.

In various embodiments, the non-sterile table 22 may be for holding orstoring sterilized and/or sterilely packaged instruments to be usedduring a selected procedure. The instrument may be delivered to thetable 22 from a storage area that may be onsite or offsite. A user orassistant during a procedure may have access to the nonsterile table 22to move or prepare instruments for a procedure, such as opening apackage of a sterile instrument or accessing an instrument tray. Thefirst sterile table 24 may be a staging area for placing instrumentsthat are to be used during a selected procedure that had been opened orunwrapped in preparation for use during the procedure. Sterile area 26may be for positioning instruments immediately prior to being usedduring a selected procedure and moved into a surgical volume or arena30. In addition, a further sterile staging area may be positionedsubstantially adjacent to a patient or subject 34 such as on or adjacentto an operating room table or patient support 38. In addition, a used orafter use table or area 39 may also be present for locating or placinginstruments after use in the operating arena 30.

At each of the various locations, including the nonsterile table 22, thefirst sterile table 24, the second sterile table 26, and the operatingarena 30, and the after use area 39 one or more reading oridentification systems or readers 40 may be provided. Readers mayinclude those disclosed in U.S. Pat. Nos. 8,233,963; 8,600,478; and/or9,265,589, all incorporated herein by reference. In various embodiments,a first reader 40 a may be positioned to near the nonsterile region 22.A second reader 40 b may be positioned at or near the first steriletable 24. A third reader 44 c may be positioned at the second steriletable 26. Further readers may include a fourth reader 40 d positioned ator near, such as to view or read, the operating arena 30 including thesubject 34. Further a reader 40 e may be positioned on or at theoperating room table 38. Other readers, as discussed herein, may also beplaced at other locations. For example, a reader 40 f may be moveable tomultiple selected locations. A large area reader 40 g may be placed toread or view a large portion and/or all of the operating theater 20.Also, a reader 40 h may be placed at or near the used area 39.

One skilled in the art will understand that each of the readers 40 a, 40b, 40 c, 40 d, 40 e, 40 g, 40 h may be substantially identical ordifferent, as discussed herein. Moreover, discussion of readers 40 maybe refer to any or all of the readers 40 a-40 h unless otherwisespecified. Moreover, it is not necessary that the operating theater 20include only or all of the readers 40 a-40 h as discussed above. Theoperating theater 20 may include less readers 40 depending upon selectedprocedures and uses. Nevertheless, the readers 40 may be used, asdiscussed herein, with a navigation system 50 to assist in tracking alocation of at least a portion of an instrument 54 prior to and duringuse of the instrument 54 on the patient 34.

In various embodiments, the instrument 54 may be transferred amongsteach of the locations, such as from the nonsterile table 22, to eitheror both of the sterile tables 24 and 26, either in series or only toone, and to the operating region or area 30. The movement of theinstrument 54 may be based upon instructions of a procedure (e.g. apreplanned and or saved plan for a procedure, such as a surgical plan)or instructions of a user, such as a surgeon 58 during a selectedprocedure. Each of the readers 40 and/or the large area reader 40 g mayread information regarding the instrument at any selected location anddetermine with a reader system 76, as discussed herein, to identify thatthe instrument 54 is at the location.

Movement of the instrument may be based on various purposes. Forexample, the surgeon 58 may instruct an assistant, such as a scrub nurseor tech, a representative, or other appropriate individual to move theinstrument 54. The selected instrument 54 may be selected based upon apredetermined procedure or plan for the procedure. The procedure may beplanned based upon instructions from the user 58, or in combination withother known instructions, and saved in a memory, such as a navigationmemory 64. The navigation memory 64 may be accessed by a navigationprocessing unit 66 either alone or in combination with a readerprocessing unit 68. The reader processor 68 may be incorporated into asystem, including either the navigation system or work station 74 or areader system 76 which may be included internally or have a separatelyaccessible reader memory 78.

It is understood that the processors or processing units, such as thosediscussed herein may include any appropriate processing unit such as anapplication specific processor including an application specificintegrated circuit “basic” and/or general purpose processor that isconfigured to execute instructions that may be stored on one or more ofthe memories, including navigation memories 64 or the reader memories78. Further, the memories, such as the navigation memory 64 or thereader memory 78 may be any appropriate memory such as a non-transitorycomputer memory including a spinning disc, solid state memory, randomaccess memory, network or offsite accessible memory, or the like.

The operating theater 20 may include the navigation system 50 having oneor more tracking systems. A first tracking system may include an opticallocalizer 84 that is configured to track and determine locations ofoptical tracking devices. Alternatively, or in addition to the opticallocalizer 84, an electric magnetic localizer 86 may be used to generateand/or receive electric magnetic fields to determine a location ofelectric magnetic tracking devices (e.g. conductive coils). A trackingdevice 90 may be associated with or connected to the instrument 54. Thenavigation system 50 may track a location (e.g. a position andorientation) of the tracking device 90. Navigation system, includingtracking of tracking devices, registration of locations of patient orprocedure space relative to an image space. Operation of navigationsystems are generally known and disclosed in U.S. Pat. Nos. RE44,305;7,697,972; 8,644,907; and 8,842,893; and U.S. Pat. App. Pub. Nos.2004/0199072, all incorporated herein by reference. Navigation systemsmay also include the StealthStation®S7® surgical navigation system soldby Medtronic Navigation, Inc. having a place of business in Colorado,U.S.A.

A patient tracking device 94 may be connected to the patient 34 and maybe referred to as a dynamic reference frame (DRF). An imaging system 100may be used to acquire images of the subject 38, such as x-ray images.The imaging system may include the O-arm® imaging system sold byMedtronic Navigation, Inc. having a place of business in Colorado,U.S.A. Other appropriate imaging systems may include magnetic resonanceimaging (MRI) system, computed tomography (CT) imaging systems, or thelike. It is understood that the imaging system 100 may not beincorporated or included in the operating theater 20, but image data maybe acquired of the subject 34 before, during, or after a procedure. Theimage data may be used to generate one or more images, as discussedherein. An imaging tracking system 104 may also be provided to assist inregistration of the images with the subject 34 in the operating space30.

The imaging system 100 may further include a source 106, such as anx-ray source and detector 110 such as an x-ray detector. The imagingsystem 100 may include an imaging system processor 116 that may be usedto assist in processing images. Further the images may be transmittedfrom the imaging system 100, such as imaging processor 116 with atransmission system 120 that may be wired or wireless and/or include aphysical media transfer. The instrument, including at least the trackingdevice 90, may be connected to a controller 124 with a communicationsystem 126, including a wired or wireless. Further, the EM localizer 86may be connected to the controller 124 with a communication system 128,including a wired or wireless system. The controller 124 may also beconnected to the navigation processing unit 66 with communication system130, that may be wired or wireless. Further, the optical localizer 84may also be in communication with a communication system 132 with thenavigation processing unit 66 that may also be wired or wireless.

The navigation work station or computer system 74, which may include orbe in communication with the navigation processing unit 66, may alsoinclude a display device or monitor 140. The monitor 140 may display animage 146 that is based upon or reconstructed for the image dataacquired with the imaging system 100. Further, the work station system74 may include various inputs such as a keyboard 150 or otherappropriate physical (e.g. human) inputs including a mouse, foot pedal,microphone, and the like. The navigation system 50, including the workstation 74, may further display an icon 160 that represents theinstrument 54 based upon information from the reader 40 and the trackedlocation of the tracking device 90. The reader 40 may be used with thereader system 76 to provide a specific and unique identity of theinstrument 54 automatically to the navigation system 50 and/or othersystems, as discussed herein. The icon 160 may, therefore, berepresented either as a graphical representation that lookssubstantially identical to instrument 54 or at least a representation ofa selected location, including a tracked location of an operativeportion of the instrument 54.

The various areas of the operating room theater 20, as noted above, maybe monitored individually by one or more readers 40, as noted above. Invarious embodiments, one or a limited number of readers may read theentire operating theater 20, such as the large area reader 40 g. Thereader 40, according to various embodiments, therefore, may be used tomonitor a single area and may have a small or tight read and/or rightvolume, such as a substantially equivalent to the operational area 30and/or one of the table or staging areas 22, 24, 26. A small read/writearea may be about 10 centimeters (cm) to about 35 cm from the individualreader 40. The single large area reader 40 g may have a read and/orright volume that is substantially equivalent to the operating room 20,including about 3 meters (m) to about 5 m from the reader 40 g. Althoughthe single read member 40 g may be provided to read or encompass a largearea, it may be provided to read the volume or area in which all of therelevant action occurs, such as in the non-sterile or sterile tables 22,24, 26 and/or the operating volume 30. The large area reader may be areader or antenna such as an Impinj Speedway xArrar UHF RFID reader,sold by atlasRFIDstore having a place of business at Birmingham, Ala. Asdiscussed herein, the reader 40 may be used to monitor one or both ofthe position and identify of instruments, including the instrument 50,within the operating theater 20 for various purposes such as determiningand/or confirming a specific identity of the instrument, use of theinstrument 54, movement or preparation of the instrument 54, etc. Forexample, in a small area reader 40, the reader system 76 may determinewhich reader 40 is able to read the instrument and thus a relativelocation of the instrument, such as at the non-sterile area 22 or at thesecond sterile area 26.

Further, each of the readers may include a transmission or communicationsystems, respectively, with the reader system 76. The communicationsystems may be any appropriate type of communication such as a wirelesscommunication (e.g., Bluetooth® communication protocols and systems,wireless area network, radio frequency transmission, etc.) and/or mayinclude wired communication systems. Regardless, each of the readers 40a-40 h may include respective communication systems 40 a′-40 h′.

With continued reference to FIG. 1 and additional reference to FIG. 2,an instrument kit 200 may include one or more members that may beinstrument 54. As discussed herein, each member may be a specific anunique instrument that may be identifiable with the reader system 76,according to various embodiments. Thus, discussion of the tools and/ormembers within the kit 200 may be generally referred to as theinstrument 54 unless referring to one or more specific instruments.Further, it is understood by one skilled in the art, that instrumentsneed not be included in a kit, a single kit, or multiple kits may beprovided individually as well.

Nevertheless, the instrument kit 200 may include a tray or othercontainer 202 that holds one or more of the instruments (generallyreferred to as instrument 54) that may be used during a selectedprocedure. The tray 202, however, is understood to be optional and neednot be provided. For example, the tray 202 may include a plurality ofinstruments including a handle or driver 210. The instrument may includeboth the handle 210 and an attachment or tip, such as a first probe 212,or may include only the tip or attachment. In various embodiments, asdiscussed herein, the handle 210 may have the tracking device 94attached thereto during a procedure. The tracking device 90 may includean optical tracking device, electromagnetic tracking device, or otherappropriate tracking device. Nevertheless, the handle 210 may have thetracking device attached at a selected and known position so that thenavigation system 50 is able to illustrate the icon 160 at anappropriate location relative to the image 146 to accurately show thetracked location of at least a tip of the instrument 212 for display onthe display and for performing a procedure.

Accordingly, the first instrument 212 may include a first probe and asecond instrument 214 may include a second probe. The difference betweenthe first probe 212 and the second probe 214 may be length, diameter, orother physical characteristics. The instrument kit 200 may furtherinclude a third instrument 216 and a fourth instrument 218. Thedifference between the third and fourth instrument 216, 218 may also bevarious dimensions, such as a length, diameter, or the like. The thirdand fourth instruments 216, 218 may be different sized awls. Theinstruments may further then include taps such as a fifth instrument 220and a sixth instrument 222. The fifth and sixth instruments 220, 222 mayalso differ in diameter or length. For example, the fifth instrument 220may be a 5.5 mm tap and the sixth instrument 222 may be a 6.5 mm tap.Instruments, generally described above as instrument 54 may also includeother surgical instruments such as scalpels or scissor instruments 224.Additionally, the instrument 54 may be individually or separatelytrackable from the handle 210 such as a trackable probe or pointer 226.

The kit 200 may also include various implants or multiple implants whichmay also be an instrument 54 as discussed herein. It is understood byone skilled in the art, however, that an implant may not be includedwith various surgical instruments such as a driver handle. Implants mayinclude a first implant 240 that may be a first screw, a second implant244 may be a second screw, and a third implant 246 may be a third screw.Each of the implants 240, 244, 246 may differ from one another in size,diameter, length, or the like. Other appropriate implants may alsoinclude disc replacement implants such as a disc replacement implant240.

Again, it is understood that the instrument 54 may generally beunderstood to be any one of a number of instruments that are used duringa procedure, as discussed further herein. Moreover, the instruments,including those discussed above in kit 200 may be provided in the singletray 202, a plurality of trays, or no tray and only separately provided.Moreover, instruments used during a procedure may be provided separatelyfrom an implant such that surgical preparation instruments may bedelivered and prepared separately from the implant to be implantedduring a procedure. Regardless, each of the instruments, according tovarious embodiments, may be identified with the reader system 76 basedon a transmission or forwarding of read information from one or more ofthe readers 40, as discussed further herein.

Regardless of the number, type, packaging, or the like of the instrument54 provided to the operating theater 20, each is a unique and individualitem. Each unique item may, therefore, be specifically and uniquelyidentified, if selected. Even if more than one type of instrument isprovided, each individual instrument may include a unique identity andmay be automatically identified as such by the reader system 76.

According to various embodiments, as discussed further herein, thereaders 40 may be used to read and transfer or forward identifyinformation to the reader system 76 to identify, uniquely, each of themany instruments provided to the operating theater 20. As discussedherein, the read information may include specific information about theinstrument 54 including size, model number, geometry, etc.Alternatively, or in addition thereto, the identity information mayinclude only an identifying number that is compared to a look-up tableto determine a unique identity and information about the instrument 54.Further, in various embodiments, the read information may include onlyan image of all or only a portion of the instrument 54.

If the kit 200 is provided to the operating theater 20, the reader 40may obtain selected information and transmit the identity informationwith the communication systems to the reader system 76 foridentification of each of the instruments provided in the kit 200 and/orincluding kit 200. Thus, each instrument 54 moved into the room 20 mayhave a specific and unique identification information that allows aspecific instrument to be identified for various purposes, as discussedherein.

In various embodiments, each of the readers 40 may be visual lightcameras (including one or more) which include sensors, such ascharge-coupled devices (CCD) and/or complementarymetal-oxide-semiconductor (CMOS) sensors. The optical sensors may also,or alternatively, sense invisible light. Further, an image and/or seriesof images (e.g. video) may be analyzed to uniquely identify theinstrument 54, including all of the instruments in the kit 200 ormembers moved from the kit 200 to selected locations. Other appropriatereaders may include microphones to sense or hear sound signals (e.g.audible, ultrasonic, infrasonic) or radio frequency antennas that maytransmit or receive radio frequencies, such as in a radio frequencyidentification (RFID) system. In various embodiments, for example, thereader 40 may be a RFID antenna able to read an indicia that may be anidentification portion or member 260 connected or included with each ofthe members of the kit 200. The ID portion 260, therefore, may be a RFIDtag that allows each identifiable instrument to be uniquelyidentifiable. For example, a first tag 260 a may be connected to and/orincorporated into the tray 202. In a similar manner, RFID tag may beincorporated into each of the unique and separate instruments asillustrated in FIG. 2 and or with the tray 202.

When the reader 40 is a RFID antenna, as is generally understood in theart, the reader 40 may transmit a signal that causes an antenna in theID portion 260 to resonate. Identification information may then betransmitted to the reader 40. The identification information may betransmitted to the reader system 76 for various purposes, as discussedherein. Various RFID tags include those sold by Xerafy company having aplace of business in Dallas, Tex. such as the Xerafy RFID tag XS seriesand/or the DOT XS RFID tag. Further, the reader 40 may include variousRFID antenna systems including small or large volume antenna systems.For example, if a small volume antenna or reader is incorporated as thesmall area readers 40 a-40 f, they may include the antennas ImpinjSpeedyway Revolution R420 RFID reader sold by atlasRFIDstore, asdiscussed above. Various other large area antenna, such as those able tocause a signal to be sent in a selected volume, such as about 5 cubicmeters, may include an antenna such as the Impinj SpeedwayxArray UHFRFID reader sold by atlasRFIDstore, as discussed above.

In various embodiments, the readers 40 may include visible light camerasincluding sensors, such as those discussed above. The visible lightsensing camera may be provided to obtain a view of the entire operatingroom 20, such as with the large volume leader 40 g or may be used toview a smaller volume, such as substantially only at or near the patientin the operating volume 30, including the smaller volume reader 40 d. Itis understood that appropriate cameras may also be used as readers 40 a,40 b, 40 c or other appropriate locations in the operating theater 20.As discussed herein, the readers 40 may include a camera that provideone or more images with visible light for analysis by the reader system76 to uniquely identify instruments at various locations, such as inpreparation for use during the surgery at each of the areas 22, 24, and26 and/or at the operating volume 50. The visible light images may bethe only information provided, according to various embodiments, fordetermining the unique identification of the instrument. Thus, theinstrument 54 may include a visual signature that is used to determinethe identity of the instrument 54, as discussed herein.

The readers 40 allow for the unique and automatic identification of eachinstrument placed at selected locations or within the room 20. Thus, thespecific item that is within the operating field or volume 30 may beidentified by one or more of the readers 40. With additional referenceto FIGS. 3A and 3B, the reader 40 may read or acquire informationregarding the specific instrument for display on the display device 140.It is understood that the display device 140 may be directly connectedto reader system 76, as illustrated in FIGS. 3A and 3B, or may beotherwise in communication with the reader system 76. For example,according to various embodiments, the reader system 76 may be incommunication with the navigation processor 66. Therefore informationfrom the navigation memory 64 may also be processed by the readerprocessor 78 and information from the reader system 76 may betransmitted to the navigation processor 66 for display on the displaydevice 140 of the navigation work station 74.

Nevertheless, the reader 40, according to any of the readers discussedabove, may read the specific instrument for identification of thespecific instrument and transmit the identification to the navigationsystem 50, such as to the navigation processor 66. In variousembodiments, the specifically identified instrument can be illustratedas a related icon, including a specific icon, on the display device 140.Moreover, specific information regarding the specifically identifiedinstrument may be used during navigation of the instrument during aprocedure, as is generally understood in the art. For example, aparticular instrument may have a length, diameter or width, angularposition relative to a tracking device, or other feature or dimensiondifferent from a another individual instrument. Therefore, the specificand accurate identification of the particular individual instrumentbeing used at any specific time during a procedure may be useful for aprocedure, such as to ensure safety of the subject 34. Moreover,misidentification or an instrument that is not appropriate for use withthe navigation system 50 during the procedure, may not be as safe or asdesirable as one appropriate and selected for the navigation system 50.

With reference to FIG. 3A a selected individual instrument includes thesecond instrument 214 attached to the handle 210. The reader 40 may readthe instrument 214 and transmit the information to the reader system 76.The reader system 76 may use the transmitted information to determine aspecific and unique instrument identification that relates to theinstrument 214. In various embodiments, thereafter, an icon 214 i may beautomatically displayed on the display device 140. The icon 214 i may bea visual representation of the second instrument 214, or may be arepresentation of a member and a second indication (such as a label) mayidentify the specific instrument 214. For example, the icon 214 i mayinclude a display that is substantially identical in appearance to thephysical instrument 214 attached to the handle 210. It may furtherinclude the specific information regarding length, diameter, and like ofthe specific instrument 214.

With reference to FIG. 3B, the specific instrument including the firsttap 220 is connected to the handle 210. The reader 40 is operable toread the instrument 220 and transmit the information from the reader 40to the reader system 76. The reader system 76 may use the transmittedinformation to determine a specific and unique instrument identificationthat relates to the instrument 220. In various embodiments, thereafter,an icon 220 i is automatically displayed on the display device 140regarding the specific instrument 220 attached to the handle 210. Again,the icon 220 i may include a graphic representation that lookssubstantially identical to the physical instrument 220 and/or may be arepresentation of that instrument with additional specific identifyinginformation of the specific instrument 220.

It is further understood by one skilled in the art that an iconrepresenting the specific instrument need not be displayed on thedisplay device 140. In various embodiments, a written or otheridentification of the specific instrument presented for use may be made.Moreover, as illustrated in FIG. 1, the icon 2214 i or 220 i may be usedas the icon 160 illustrated relative to the image 146 on the displaydevice 140. Therefore, it is understood that the icon 160 may be any theappropriate icon that is based on the specific instrument read by thereader 40.

The reader 40 may be any appropriate reader, including those asdiscussed herein. For example, the reader 40 may include a laser scannerthat is configured to scan a bar code or other indicia provided on thespecific instruments. The indicia may include the indicia 260. Invarious embodiments the reader 40 may include a scan volume that isconfigured to scan the indicia 260 to provide read information. The readinformation may then be transferred to the reader system 76 for furtheruse, as discussed further herein. The reader 40 may also include a RFIDantenna that actively receives a signal from the indicia 260 that may bean active transmission RFID tag and/or induces a transmission from theRFID tag as the indicia 260. In various embodiments, therefore, theindicia 260 may be an RFID tag and selected information may be storedthereon that is retrieved by the reader 40 and transferred to the readersystem 76. In various embodiments the information stored and received bythe reader 40 may include an identification alphanumeric code (e.g. anetched or printed number or word) that is transmitted to the readersystem 76. Further, specific identification information, such asspecific dimensions, particular identification information, includingtype of instrument, manufacturer of instrument, or a security code, maybe also safely transmitted to the reader 40, such as from the RFID tag.

In various embodiments, the reader 40 may also and/or alternativelyinclude a microphone that receives a sound signal. The sound signal maybe an audible, an infrasonic, or an ultrasonic sound signal. The soundsignal may be read by the reader 40 and transmitted into the readersystem 76. Further, the reader 40 may include a visible light opticalcamera that is able to view a scene within the room 20, or a selectedportion thereof including the areas 22, 24, 26, 30, and 39. The scenemay include the instrument 54 alone and/or the indicia 260. For example,the reader 40 may view only the instrument 214 and not the indicia 260.The view of the instrument 214 may be transmitted to the reader system76 to make a determination of the unique identity of the instrument 214.As discussed herein, various processes may be used for making thedetermination, such as with a trained neural network including aconvolution neural network (CNN). The indicia 260 may also be viewed inthe scene by the reader 40 and a determination may be made based on theindividual indicia 260 the unique identity of the instrument 214. Theindicia 260 may include, therefore, a visible signature that may beincorporated in the CNN for identifying the instrument 54.

With reference to FIG. 4, a use/flowchart 300 is illustrated regardinguse of the reader 40 with the reader system 76 in combination withselected outlets for various purposes, including use by the navigationsystem 50. The reader 40, according to various embodiments as discussedabove, may be used to read information, including such as from theindicia 260 and/or directly on the instrument 54, to allow for adetermination of the specific instrument, including the instrument 214or the instrument 220. FIG. 4 in flowchart 300 illustrates an exemplaryprocess, according to various embodiments, for an automatic uniqueinstrument identification and use of the unique instrumentidentification.

The identification and use process 300 may begin in start block 302. Aninstrument may be placed in a reader volume or area in block 310. Asdiscussed above, the instrument 54 may be positioned at specificlocations, such as at the non-sterile table in area 22 or one or more ofthe sterile tables or areas 24, 26 or at the operation volume 30. It isfurther understood that the instrument 54 may be positioned at otherlocations, such as in the after use location 39, an alternativeoperating location (e.g., harvest location), or other appropriatelocations. As discussed above or herein, therefore, the reader 40 may beused for identifying a general location of the instrument (e.g. at oneof the selected locations) and identify whether or not it is ready foruse, used, or moved from one or more pre-defined locations.Alternatively, a large area reader, such as the reader 40 g, may be ableto read several individual locations and identify that an instrument iswithin, such as within a selected error, a particular region. Forexample, the reader 40 g may be able to identify that an instrument iswithin at least 30 cm of a selected area. The large area reader 40 gneed, therefore, not be placed adjacent to or near a specific area, butmay be able to read a large area and provide information to the readersystem 76 to identify instruments in specific areas and the identity ofthe specific instruments. In various embodiments, one or more of thelarge area readers 40 g may be able to determine and or triangulate(e.g. with a processing system for calculating a location) a location ofthe instrument within an area, such as in the tray 202, near apreparation area, and/or a surgical area.

When the instrument is placed in a selected reader volume or area inblock 310, the instrument may be read in block 314. As discussed above,the instrument may be read in block 314 according to a plurality ofmanners. In various embodiments, the indicia 260 may include a RFID tag.The RFID tag may include read or write regions that may be accessed bythe reader 40. For example, the RFID tag may be read to provide aspecific identification number to the reader. Further, the instrumentmay be read by receiving specific identification information, such as amodel number, size, or the like to provide specific informationregarding the instrument to the reader system 76. Further, the reader 40may include an optical camera that images the instrument, such as bybeing sensitive to visible light. The image of the instrument 54 mayinclude an image of all or a part of the instrument 54 and the image maybe transferred as a still image, a series of still images, or a motionvideo. Further, the reader image of the instrument may be compressed forvarious purposes to transmit the image data.

The reader images acquired may be used to identify the instrument basedupon the all or a portion of the reader image, such as with a trainedneural network classification scheme, including a convolution neuralnetwork (CNN) system, as is generally understood by one skilled in theart. Various appropriate machine learning and/or neural network systemsinclude the Tensorflow™ open source machine learning system and theCaffe deep learning/machine leaning system as developed at BerkeleyArtificial Intelligence Research as a part of University of California.A CNN may be trained and implemented as disclosed in A. Krizhevsky, I.Sutskever, G. E. Hinton, ImageNet Classification with Deep ConvolutionalNeural Networks, Advances in Neural Information Processing Systems 25(NIPS 2012), incorporated herein by reference.

A CNN may be implemented on a selected processor system which mayinclude a graphical processing unit (GPU) as a hardware element fortraining and deploying the CNN. It is understood that a centralprocessor unit (CPU) may also be used to train and implement the CNN.Moreover, the GPU or CPU may be include in the reader system 76, thenavigator system 74, or other appropriate processor. Convolutionalneural networks, as discussed herein, may be used for object recognitiontasks. CNN's allow for training accurate models which are able to copewith image variations such as rotation, scale, illumination, backgroundchanges, etc. In various embodiments, the CNN may include a learningmodule is made that is able to learn from data. A learning database, forthe learning module, containing many surgical tool images in differentposes, labeled by tool name, type, etc. may be acquired using a cameraor a video camera. The CNN may also include a recognition module, namelythe use of the CNN previously trained on the training database torecognize, in real time, surgical tools in newly captured images in theoperating room. The images are generally visible light images. Moreover,the CNN may be implemented to automatically identify the instrument 54that is imaged by the reader 40.

In the CNN, in various embodiments, may include and/or account for allinformation regarding an image, such as including all of the pixels andinformation regarding the pixels (e.g., color and the like) areconvolved in a convolutional layer that may be applied to a depth of animage. The convolutional layers are saved or formed as filters orkernels that may be applied to a newly input image. Therefore, thereader memory 78 may include a plurality of learned instruments (e.g.,with imaging an instrument that is identified by a manufacturer prior tothe use by the user 58). In one example, a plurality of images of theinstrument 214 may be used for the reader system 76 to “learn” theinstrument 214. After learning, when an instrument is read in block 314,the reader processor 68, executing instructions recalled from the readermemory 78, including the CNN regarding the identification of aninstrument, may determine, automatically, a unique instrumentidentification, such as of the specific instrument 214. To determine theinstrument identity, a probability of the currently imaged instrumentbeing one of the instruments that trained the CNN may be determined,according to the CNN system. The instrument identity, such as a specificidentify of the unique instrument, may be output of the probability isabove a selected threshold, such as about 50%, about 60%, or anappropriate or selected probability.

Once the instrument is read in block 314, the transmission of the readinformation to the reader system 76 may be made in block 320. Thetransmission of information may include transmission of an ID code fromthe RFID tag, a barcode number or alphanumeric sequence, or the image ofthe instrument. The transmitted information from block 320 may be usedto identify the specific instrument in block 322, such as by the readersystem 76. In various embodiments, the reader memory 78 may include adatabase, such as a look-up table, that includes information or acorrelation or relationship between identities or specific and uniqueinstruments that relate to possible inputs. The database may haveidentities of one or more specific instrument.

For example, the look-up table may correlate a specific identificationnumber, such as one included on the RFID tag as the indicia 260, touniquely identify or provide the identity of the specific instrument. Invarious embodiments, identifying the specific instrument in block 322may also include the execution of the CNN to identify the specificinstrument based upon the transmitted image of the instrument from block320 read in block 314. The automatic identification may be based oninstructions that are executed by a selected processor system, such asthose discussed herein, that receive the input and access the databaseto determine proper outputs for identification, if possible.

It is understood by one skilled in the art, however, that the reading ofthe instrument 54 in block 314 may be any appropriate reading ofinformation. Identification of the specific instrument in block 322 maybe based upon various information, such as accessing a look-up table tocompare the look-up table to the read information, using the specificread information (e.g., transmitted specific instrument identificationinformation from a RFID tag, image of the instrument, image of theindicia 260, etc.), or other appropriate information. In variousembodiments, however, the identification is automatic by executing theselected instructions, which may also be accessed from a memory, toidentify the instrument based on the received or read information. Theidentification of a specific instrument may then be output, as discussedherein.

Once the instrument is identified in block 322, such as with the readersystem 76, the specific instrument identification may be transmitted orused in block 330. The use of the identity of the specific instrumentmay be according to one or more uses, as discussed further herein.Further, the specific identity of the instrument may be transmitted toother systems, such as the navigation system 50. The navigation system50 may use the specific identity of the instrument 54 for use innavigating a procedure, as discussed above and further herein. Furthertransmission of the specific identity of the instrument may be comparedto various plans, either in the navigated procedure or in otherprocedures, as also discussed further herein.

The specific identity of the instrument, such as the instrument 214illustrated in FIG. 3A, can be used for various purposes from block 330.For example, according to various embodiments, an output of anincorrect, wrong and/or non-approved instrument may be made in block336. The output of the wrong or incorrect instrument may be for variouspurposes and may take any appropriate form, such as a visual, tactile,or audible warning. The warning output may further include stopping orfreezing navigation and/or removing a display of a representation of theinstrument from a display. For example, a predetermined plan for aprocedure on the subject 34 may be stored in the navigation memory 64and/or or the reader memory 76, or other appropriate memory. Thespecific identity of the instrument, especially when moved to the finalprep sterile stage or area 26 and/or the procedure area 30, may becompared to a particular planned stage or point of the procedure (e.g.,as identified by the user 58, or such as following the use of a previousinstrument) and a warning may be provided that the current instrument isnot correct.

Further, a warning may regard that the instrument, such as theinstrument 214, is not verified (e.g. properly manufactured, sized,etc.) or appropriate for use with the navigation system 50. For example,the instrument that is identified may be identified as not having beensterilized prior to use. Such a warning may be identified or made whenthe instrument is moved to the initial or non-sterile area 22. Inaddition, if the reader system 76 is unable to specifically identify theinstrument the warning may also be output. Accordingly, it is understoodthat the identification of the specific instrument may occur at anylocation and that various outputs may be made at any appropriate time.Further, it may be identified that the instrument is not appropriate forthe particular handle, such as the handle 210, already identified by thereader 76 or input by an appropriate user, such as the user 58. Outputwarnings, therefore, may include various warnings to the user 58, orother appropriate individual, regarding the specifically identifiedinstrument.

The specifically identified instrument may also be compared to arecalled plan to determine the proper instrument in block 340. Asdiscussed above, an output warning may be that an instrument isincorrect for a particular procedure or predetermined surgical planand/or that the uniquely identified instrument may be, when compared tothe plan, improper at a particular time, not a proper type based upon apreviously used instrument, etc. For example, one of the fifth or sixthinstrument 220, 222 may include a specific diameter and an implant maybe an implant screw such as one of the screws 240, 244, or 246. Theidentification of the specific instrument, including one of the screws240, 244, 246, may be compared to the previously used tap 220, 222 toconfirm the appropriate size of the read implant. Further, theinstrument may include an implant, such as the implant 250. The kit 200may include a plurality of types of implants, such as sizes, geometries,or specific features, and the identification of the specific instrumentin block 322 may be compared to a predetermined plan in block 340 thatis recalled from an appropriate memory, such as the navigation memory64, for performing a procedure.

A previously determined plan, including a previously determined surgicalplan for stages of a procedure and the type of implant, may be stored inthe navigation memory 64. It is understood that other appropriate plansmay also be determined, such as a manner of assembling a device,including a robot assembly, and a car frame, or the like or otherappropriate predetermined plan.

Once the comparison is made in block 340, an output of the determinationmay be made in block 344. The output of the determination may include awarning, similar to the warning output in block 336. The output of thedetermination in block 344, however, may be based specifically on thecomparison of the specifically identified instrument in block 322 whencompared to the plan that has also been predetermined. The output may bean auditory output, a visual output (e.g., on the display device 140),or other appropriate output.

The use or transmission of the specific instrument identity may also bereceived into an instrument management system in block 350 such as forinstructing and/or augmenting the instrument management system. Forexample, the instructing and/or augmenting nay be for updating adatabase for the instrument management system (e.g. inventory, cleaningregimen, etc.) or instructing actions to be taken place regardingselected instruments or sets of instruments. The instrument managementsystem may be used to save or store that a specific instrument has beenused for determining that the instrument 54 must be cleaned prior to afurther use and/or that it must be disposed of and reordered forpossible future cases of a similar procedure. Additionally, thespecifically identified instrument in a selected location, such as onone of the sterile areas 24, 26 and/or in the procedure area 30 and/orin a post-procedure area may also assist in identifying instruments andimplants for various purposes such as for compensation, reordering (asdiscussed above), ensuring that selected instruments are removed from aselected area (e.g., sponges from the procedural area) and otherpurposes.

Further, the received information in block 350 may be used to compare toa specific procedure to ensure that instruments are prepared for futureprocedures in block 356. For example, the predetermined plan stored inthe navigation memory 64 may be based upon a general plan used by theuser 58. Over time, it may be determined that all instruments in the kit200 are not used and that certain instruments may not be necessary andtherefore not provided for use. This may provide for efficient provisionof instruments and implants for a procedure. In addition, it may bedetermined that certain instruments are beneficial to be used during aprocedure and those may also be included in the kit 200 for future use.The comparison and determinations may then be stored in block 358 suchas in a hospital storage and management system and/or in a specific userstorage system.

Further, the use of the specific instrument identity may be transmittedto and received in the navigation system 50 in block 370. It isunderstood, however, that the reader may be integrated into thenavigation system in a selected manner. The received specific identityin block 370 may then be used to display a specific instrument icon inblock 374. As discussed above, the display device 140 may display theicon 160, such as the specific instrument icon 214 i that relates to thespecific instrument 214. The navigation system 50, after receiving thespecific identified instrument, may also be used to determine a properspecific instrument based on a recalled predetermined plan, such as aprocedure or surgical plan in block 380. The compared plan may be anavigation plan and based upon the use of previously navigatedinstruments.

Again, the navigation system 50 may access the plan, that may be storedin the navigation memory 64, and compare the current specificallyidentified instrument, or at least one specifically identifiedinstrument in the procedure area 30, relative to a previously usedinstrument, such as one moved to a selected location relative to thepatient 34. Therefore, although the procedure area 30 may include twotaps of two specific sizes, the navigation system 50 may navigate anddetermine a location of only one of the instruments being moved to forma tapped bore in the subject or patient 34. Therefore, the navigationsystem 50 may compare not only to previously determined surgical plan,but also a previously used instrument moved to a specific locationrelative to the subject 34 and compared now to a specifically identifiedinstrument. It is understood, however, that a comparison to only theplan or to only the previously used instrument may be made.

The navigation system 50 and/or the reader system 76 may make thedetermination that the current read instrument is proper and follow the“yes” block 382 to navigate a planned procedure in block 384. Navigatedprocedures may be any appropriate procedures, as is generally understoodin the art. If a determination that the instrument is not proper, then a“no” path 390 may be followed and an inoperative warning may be made inblock 392. The inoperative warning may include stopping navigation,providing a visual or auditory indication of an improper instrument, orother appropriate warnings. Nevertheless, the navigation system 50 mayreceive the specifically identified instrument from the reader system76.

As noted above, it is understood that the reader system 76 mayautomatically identify the specific instrument based upon informationreceived from the reader 40. The instrument 54, or plurality ofinstruments, may be placed in the reader volume and the reader 40 mayread information regarding the instrument 54, such as from indicial 260and/or an image of the instrument 54, and the read information may betransmitted to the reader system 76 for an automatic identification ofthe specific instrument. The automatic identification may be theprocessor 68 executing selected instructions to identify the instrument54. Selected instructions may include comparing the read information toa look-up table stored in a memory to determine the specific identity ofthe instrument and/or applying the CNN to determine the identity of aninstrument in an image. It is understood that the identity of theinstrument 54, however, may be further compared to a look-up table thatincludes specific information regarding the instrument, such as thegeometry or the like of the instrument for use in navigation or otherprocedures. The identification of the instrument may be substantiallyautomatic by the reader system 76 and providing for various otherpurposes, as discussed above and illustrated in the flowchart 300.

Automatic identification may allow a user to not be required tootherwise identify the instrument or request the identity of aninstrument be input to a navigation system 50 for performing a procedureor for other purposes, such as determining the location of an instrumentor the use of an instrument. It is understood, however, that theidentification of the instrument in block 322 may also allow a user afinal determination, but allow for a display of a limited list ofpossible identities for a final selection by a selected user, such asthe user 58. Moreover, the automatic identification of specificinstruments in block 322 may be used for transmitting in block 330 forother purposes such as preparing the navigation 50 for a selectedprocedure. The navigation system 50 may include various modules orinterfaces for different selected procedures, such as one interface andpossible instrumentation for a deep-brain simulation and a differentinterface and possible instrumentation set for a spinal implant.Therefore, the automatic identification of specific instruments in block322, such as ones placed in a non-sterile area 22, may assist in settingup the navigation system 50 for an appropriate procedure. It isunderstood, however, that any appropriate system may be set up for aselected procedure based upon the receiving of instruments.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

Example embodiments are provided so that this disclosure will bethorough, and will fully convey the scope to those who are skilled inthe art. Numerous specific details are set forth such as examples ofspecific components, devices, and methods, to provide a thoroughunderstanding of embodiments of the present disclosure. It will beapparent to those skilled in the art that specific details need not beemployed, that example embodiments may be embodied in many differentforms and that neither should be construed to limit the scope of thedisclosure. In some example embodiments, well-known processes,well-known device structures, and well-known technologies are notdescribed in detail.

What is claimed is:
 1. A method of performing a procedure, comprising:acquiring a current image of an instrument in a selected area;transmitting the current image of the instrument; and executinginstructions with a processor system to: determine an instrumentspecific identity of the instrument based on the transmitted currentimage by executing instructions with a processor; and output theinstrument specific identity of the instrument for the procedure; andevaluating the instrument based on the output instrument specificidentity of the instrument; wherein executing instructions with theprocessor system for determining the instrument specific identity of theinstrument based on the transmitted current image includes: accessing atrained convolutional neural network (CNN) that has been trained withtraining images of a plurality of selected known instruments to defineat least one kernel for identifying at least one of the plurality ofselected known instruments; and determining a probability that thecurrent image includes at least one selected known instrument of theplurality of selected known instruments based on the trained CNN.
 2. Themethod of claim 1, further comprising: executing further instructionswith the processor system to determine the instrument specific identityof the instrument including: training the convolutional neural networkto determine at least one filter; saving the trained convolutionalneural network in a memory system; receiving the transmitted currentimage of the instrument; and applying the at least one filter to thetransmitted current image of the instrument.
 3. The method of claim 2,further comprising: recalling, by executing further instructions withthe processor system, a predetermined plan including a plannedinstrument specific identity; and executing further instructions withthe processor system to compare the output instrument specific identityto a predetermined plan including a planned instrument specificidentity.
 4. The method of claim 3, further comprising: executingfurther instructions with the processor system to output a warning ifthe output instrument specific identity is not a selected instrumentspecific identity.
 5. The method of claim 4, further comprising:recalling the predetermined plan for the procedure; wherein the selectedinstrument specific identity is selected based on the recalledpredetermined plan.
 6. The method of claim 1, further comprising:reading information of the instrument including receiving informationfrom a radio-frequency identification device; and transmitting thereceived information from the radio-frequency identification device. 7.A system to evaluate instrumentation for use while performing aprocedure, comprising: a light sensor system configured to acquire acurrent image of the instrument; a transmission system configured totransmit the current image of the instrument; a processor system toexecute instructions to: determine an instrument specific identity ofthe instrument based on the transmitted current image; and output theinstrument specific identity of the instrument; and a memory system;wherein the memory system has stored thereon a convolutional neuralnetwork (CNN) that is trained with training images of a plurality ofselected known instruments; wherein the CNN includes at least one kernelto output a probability that the current image includes at least oneselected known instrument of the plurality of selected knowninstruments; wherein the processor system is configured to access thememory system.
 8. The system of claim 7, wherein the current image fromthe light sensor system is a visible light image of the instrument. 9.The system of claim 7, wherein the processor system to executeinstructions to determine the instrument specific identity of theinstrument based on the transmitted current image includes analyzing thecurrent image with the at least one kernel of the CNN.
 10. The system ofclaim 9, wherein the processor system to execute instructions to outputthe instrument specific identity of the instrument includes outputtingthe instrument specific identity of the instrument when the probabilityis greater than a threshold probability.
 11. The system of claim 10,further comprising: an identification member fixed to the instrument;wherein the current image includes an image of the identification memberwherein the determined instrument specific identity of the instrument isbased at least on the transmitted current image including the image ofthe identification member.
 12. The system of claim 7, furthercomprising: a tray including a plurality of instruments; wherein thecurrent image includes an image of the plurality of instruments; whereinthe output the instrument specific identity of the instrument includesan instrument specific identity for each instrument of the plurality ofinstruments.
 13. The system of claim 7, wherein the processor system isoperable to execute further instructions to: output a warning to a userbased on the output of the instrument specific identity of theinstrument.
 14. The system of claim 7, wherein the processor system isoperable to execute further instructions to: determine whether theoutput of the instrument specific identity of the instrument is a properinstrument when compared to a recalled plan; and output thedetermination.
 15. The system of claim 7, wherein the processor systemis operable to execute further instructions to: transmit information toan instrument management system based on the output of the instrumentspecific identity of the instrument.
 16. The system of claim 7, furthercomprising: a surgical navigation system having a display device;wherein the surgical navigation system receives the output of theinstrument specific identity of the instrument and automaticallydisplays a representation of the specific identity of the instrumentwith the display device.
 17. A method to evaluate instrumentation foruse while performing a procedure, comprising: placing an instrument inan identification area; acquiring a current image of the instrument witha light sensor system; transmitting the current image of the instrumentfrom the identification area; executing instructions with a processorsystem for determining an instrument specific identity of the instrumentbased on the transmitted current image; and outputting from theprocessor system the instrument specific identity of the instrument;wherein executing instructions with the processor system for determiningthe instrument specific identity of the instrument based on thetransmitted current image includes: training a convolutional neuralnetwork (CNN) with training images of a plurality of selected knowninstruments; accessing the trained CNN; determining a probability thatthe current image includes at least one selected known instrument of theplurality of selected known instruments based on the trained CNN. 18.The method of claim 17, wherein the current image is based on a lightsensor system that is a visible light imager.
 19. A method to evaluateinstrumentation for use while performing a procedure, comprising;placing an instrument in an identification are; acquiring a currentimage of the instrument with a light sensor system; transmitting thecurrent of the instrument from the identification area; executinginstructions with a processor system for determining an instrumentspecify identity of the instrument based on the transmitted currentimage; and outputting from the processor system the instrument specificidentity of the instrument; wherein executing instructions with theprocessor system for determining the instrument specific identity of theinstrument based on the transmitted current image includes: accessing atrained convolutional neural network (CNN) that has been trained withtraining images of a plurality of selected known instruments to defineat least one kernel for identifying at least one of the plurality ofselected known instruments; and determining a probability that thecurrent image includes at least one selected known instrument of theplurality of selected known instruments based on the trained CNN. 20.The system of claim 17, further comprising: analyzing the current imageincluding an image of a plurality of instruments in a tray; andoutputting an instrument specific identity for each instrument of theplurality of instruments.